FDA approves COVID-19 vaccine for Phase 2 clinical trial

The first volunteer received the vaccine in March

Photo (c) simon2579 - Getty ImagesA vaccine against the coronavirus (COVID-19) may be closer to being ready for the public than health experts have predicted.

Biopharma firm Moderna reports that the U.S. Food and Drug Administration (FDA) has approved its COVID-19 vaccine for a Phase 2 clinical trial -- which will test whether the drug is effective. The company said the trial, using 600 volunteers, will begin soon.

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stéphane Bancel, Moderna’s CEO.

The company is already looking ahead to a Phase 3 study, which Bancel said could begin as early as this summer.

“Moderna is now preparing to potentially have its first BLA approved as soon as 2021,” she said. “We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective.”

Years away?

Some health experts have predicted a proven vaccine could be two years away, and that may turn out to be the case. But the speed in which medical researchers have developed vaccine candidates is unprecedented.

The Moderna vaccine was given to the first volunteer in Seattle in mid-March. It was developed in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID), whose director, Dr. Anthony Fauci, is a key member of the White House task force on COVID-19.

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” Fauci said in March “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

The Phase 1 trial showed that the vaccine is safe for humans. The Phase 2 trial will determine if the vaccine is effective against the disease. If it is, the vaccine then goes to a Phase 3 trial, which can sometimes take years to complete.

But just like the speedy FDA approval of the Gilead Sciences drug remdesivir as a COVID-19 treatment, the Moderna vaccine could find itself on the regulatory fast track. The company is already producing quantities of the vaccine just in case.

Mark Huffman has been a consumer news reporter for ConsumerAffairs since 2004. He covers real estate, gas prices and the economy and has reported extensively on negative-option sales. He was previously an Associated Press reporter and editor in Washington, D.C., a correspondent for Westwoood One Radio Networks and Marketwatch.